Tech Bulletin | March 2018

 

Stability Program and Annual Stability

Over the next few months DYNALABS will be sending reminders to our current clients that have performed a stability study per FDA and ICH requirements. DYNALABS recommends testing the stability of at least 1 lot per API per year.An ongoing stability study should be conducted after any significant change or significant deviation to the synthetic route, process, or container closure system which may have an impact upon the stability of the API.The stability of the API should be monitored according to a continuous and appropriate program that will permit the detection of any stability issue (e.g. changes in levels of degradation products). The ongoing stability program should be described in a written protocol and the results presented in a formal report assessing the following:

  • review of critical in-process control and critical API test results.
  • review of all batches that failed to meet established specification(s).
  • review of all critical deviations or non-conformances and related investigations.
  • review of any changes carried out to the processes or analytical methods.
  • review of results of the stability monitoring program.

For more information, sources, or consulting please contact marketingtechnicalservice@dynalabs.us

Aqueous Products
Water Activity per USP <51> and USP <1112>

In our February technical bulletin, we provided an update on our recommendation to perform USP <51> testing on measuring the stability of a product. It is important to also consider which products should adhere to USP <51> specifications.

For the purpose of compendial chapter: <51> ANTIMICROBIAL EFFECTIVENESS TESTING, products that must adhere to the specifications are defined as aqueous products which have a water activity of more than 0.6 aW (common Bees’ Honey exhibits a water activity of 0.6 aW).

Reduced water activity assists in the prevention of microbial proliferation in pharmaceutical products; the formulation, manufacturing steps, and testing of nonsterile dosage forms should reflect this parameter. Other product attributes, such as, low or high pH, absence of nutrients, presence of surfactants, antimicrobial agents, in addition to low water activity, help to prevent microbial growth.

Please reference Application of Water Activity Determination to Nonsterile Pharmaceutical Products <1112> for additional details, it should be noted that more resistant microorganisms, including spore-forming Clostridium spp., Bacillus spp., Salmonella spp. and filamentous fungi, although they may not proliferate in a drug product with a low water activity, may persist within the product.


If you have any questions, please reach out to your Customer Support Specialist at info@dynalabs.us

DYNALABS has updated our API list for Potency Testing to remove the following:

  • Etomidate
  • Spironolactone
  • Hyaluronic Acid

An updated, comprehensive list can be found by clicking the link here. Any active that is dictated with “Special” in the tier column requires a quote/pre-approval before proceeding with testing.  If you wish to test something not on this list, please contact DYNALABS for Method Feasibility and Method Development.

DYNALABS has updated and improved our API list for Potency Testing, New Method Transfers:

  • Betamethasone Acetate- Tier 2
  • Bumetanide- Tier 1
  • Methohexital Sodium- Tier 1
  • Rocuronium Bromide- Tier 2

Clients with existing Validation Extensions can send validation extension materials for these methods until April 25th for no charge. Please request quotes for extensions. After that time normal charges will occur for validation extensions.

Changes / Improvements

With DYNALABS’ commitment to continuous quality improvement, we are making several changes to our testing options. These changes will showcase a more accurate representation of tests we offer, and will provide better data analytics and reporting. As always, DYNALABS strives to provide our customers with the best options.

Please click here to download a list that provides a detailed summary of these changes.


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